The purpose of this study is to investigate whether S-adenosylmethionine (SAMe), a natural substance available as a nutritional supplement, can influence blood levels of homocysteine (Hcy). More specifically, we will determine if chronic oral SAMe administration affects homocysteine metabolism in patients with vascular disease who have mild to moderate hyperhomocysteinemia.

To determine the effect of oral SAMe (1200 mg/day) on plasma total homocysteine (tHcy) and asymmetric dimethylagrinine (ADMA) levels in subjects with mild to moderate hyperhomocysteinemia. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the effect of oral SAMe (1200 mg/day) with and without supplementation of folate, vitamin B12 and B6, on plasma homocysteine levels in patients with mild to moderate hyperhomocysteinemia. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

The purpose of this study is to investigate whether S-adenosylmethionine (SAMe), a natural substance available as a nutritional supplement, can influence blood levels of homocysteine (Hcy). More specifically, we will determine if chronic oral SAMe administration effects homocysteine metabolism in patients with vascular disease who have mild to moderate hyperhomocysteinemia through the following specific aims:

Specific Aim 1 - To determine the effect of oral SAMe (1200 mg/day) on plasma total homocysteine levels in subjects with mild to moderate hyperhomocysteinemia.

Specific Aim 2 - To determine the effect of oral SAMe (1200 mg/day) with and without supplementation of folate, vitamin B12 and B6, on plasma homocysteine levels in patients with mild to moderate hyperhomocysteinemia.

Must have a serum homocysteine value greater than or equal to 14 μmol/L

Stable weight 3 months prior to study participation

Exclusion Criteria:

Subjects with a BMI greater than 35 or less than 18

Currently taking B 100 or other high-dose B vitamin supplements within the past 12 months

Taken methionine or SAMe supplements within the past 3 months

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00473200